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Completed

NCT Number: NCT05878899

Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the Geneva University Hospitals

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Geneva University Hospitals

Geneva, 1205, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adult women within 48h of delivery, with:

  • ≥2 of the following risk factors Age ≥35 years Pre-pregnancy BMI 30.0-34.9kg/m2 Current smoking Elective cesarean section Postpartum hemorrhage Antenatal immobility
  • and/or ≥1 of the following risk factors: Emergency cesarean section Pre-pregnancy BMI ≥35kg/m2 Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) Pre-eclampsia Pre-term delivery (<37th week of gestation) Peripartum systemic infection (defined as fever with use of antibiotics) Intra-uterine growth restriction (birth weight <5th percentile)

Exclusion criteria

  • any indication for therapeutic anticoagulation
  • a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia)
  • an increased bleeding risk
  • a contra-indication to the use of heparin

Treatment and study plan

Enoxaparin

Drug

Prophylactic dose of enoxaparin once daily for 10 days after delivery.

Primary outcomes

  1. Recruitement rate

    Time frame: 6 months

    Number of study inclusion per month

  2. Study participation

    Time frame: Within 48 hours after delivery

    Proportion of eligible women who are presented the study and who accept to participate

Secondary outcomes

  1. Venous thromboembolism

    Time frame: Within 90 day after delivery

    Pulmonary embolism and deep vein thrombosis

  2. Bleeding

    Time frame: Within 90 day after delivery

    Major and clinically relevant non-major bleeding

  3. Surgical site complication

    Time frame: Within 90 day of delivery

    Cesarean section site complication

  4. Heparin-induced thrombocytopenia

    Time frame: Within 90 day of delivery

  5. Septic pelvic thrombophlebitis

    Time frame: Within 90 day of delivery

  6. All-cause mortality

    Time frame: Within 90 day of delivery

  7. Satisfaction with study intervention

    Time frame: After completion of the 10 days of study drug

    Satisfaction based on TSQMII questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Acronym: PP-HEP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 26, 2023
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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